Two Day Common Technical Dossier Course: (London, United Kingdom - December 5-6, 2017) - Research and Markets

DUBLIN--()--Research and Markets has announced the addition of the "Common Technical Dossier" conference to their offering.

Project Management/Collection of Critical Documents for Chemistry, Manufacturing and Control (CMC) for Global Registration (CTD) & Incorporate Quality by Design within the CTD.

This two-day course will provide you with a clear understanding of the regulatory and technical requirements for CMC management of your full and generic application in major markets of EU and USA. Furthermore, the course examines the requirements for Global roll out of the dossier to ROW regions including, LATAM, ASEAN, MENA and CIS territories.

You will increase your ability to manage all aspects of development of the CMC aspects of applications after two days of intensive lectures, group work, and discussion sessions, covering everything you need to know about compiling the chemistry and pharmacy

Agenda:

Day 1 Schedule

What is the CTD? The road map to Module 3 Understanding ICH

- Assessing the impact of the harmonisation - ICH guidelines

Preparing the drug substance section of the application - US and EU

- Analysing the needs for the section

- How to submit information - Drug Master Files, Certificates of Suitability, other methods

- European Submissions, CEP and ASMF requirements

- Detailed information requirements for the section

- Q11 explained - EU and US expectations of FMEA analysis

- Development expectations and scale-up requirements

- Specific examples on EU / US format and guidance

GMP for Active Substances

- Examining GMP requirements and EU and US expectations, inspection timing and interactions and contractual obligations

Case study: Essential information from API suppliers

- The case study will allow participants to identify and understand the essential data requirements from API suppliers for submission of generic applications

Examining the content of the sections concerning the drug product. Composition and development of the drug product

- Defining the formulation

- Identifying the data needs for the pharmaceutical development section, explaining QBD and FMEA requirements

- Multiple examples of Development Report content - practical for table of contents and creation of QBD Pyramid

Day 2 Schedule

(All Module Sections include Example Sections for Writing)

Writing the section on manufacture of the drug product and process validation

- Examining the content of the section: How much information to provide

- Defining the difference between process development and validation and looking at validation expectations in today's environment

- Examining the content of the section

Writing the sections on Excipients and Packaging Components

- Control of the Excipients/Packaging Components

- Examples of data expectations

- Examining maintaining these sections

Writing the sections on control of the finished product and Case Study

- Examining the content of the section

- Control of the drug product

- Examples of specifications for Multiple Product Types

- Examples for Method Summaries

Writing the stability section

- Examining the content of the section

- Evaluation of stability data and the impact on shelf

The function and content of the Quality Overall Summary

- Overview of the current approaches

- What is the Expert Report: Practical involvement of the expert

- QOS explained and compared with Expert Report

- Detailed content of the QOS

Examining Global Roll-out of CTD - Module 3

Examining Change Control - Practical tips

Practical Exercise in Generic Development

- Identifying 10 - stage plan for developments

For more information about this conference visit http://www.researchandmarkets.com/research/qsxp57/common_technical

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Pharmaceuticals

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Pharmaceuticals